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Practice Tip: The Physician Labeling Rule
On June 30, 2006, new regulations governing the format and content of prescription drug labels went into effect. These changes marked the first major overhaul of drug labeling rules in more than 25 years.
The primary purpose of the changes is to make labels more accessible to practicing physicians. When the FDA first issued the rule in December 2000, it expressed concern that product labels had become too cluttered as a result of growing chemical complexity of drugs and the effects of product liability litigation. The new label, including a 'highlights' section, a table of contents, and a streamlined adverse reaction section, is designed to return the product label to its originally intended purpose as a useful and clear tool for practicing physicians.
In issuing the final rule, the FDA clearly staked out its position that these new rules are intended to clarify long-standing principles regarding product labeling, what should (and should not) be in a label, and the FDA's role in approving label changes. As part of this statement, the FDA reiterated its position that approved labels generally pre-empt state tort lawsuits that claim a different label (or warning) was appropriate. The details of these pre-emption issues are the subject of much litigation and not the central focus of this article.
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